Odense University Hospital
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Odense, Denmark
Not yet recruiting
Study on Everolimus to Improve Bone and Muscle Health in Elderly with Stable Conditions
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of the medication Everolimus on the health of elderly individuals. The study aims to see if Everolimus, which is a type of drug known as a rapamycin analog, can help prevent bone loss that comes with aging. It also looks at whether the drug can improve muscle function and reduce some of the biological processes that contribute to aging. The trial involves participants who are generally healthy elderly people with stable medical conditions.
Participants in the study will be given either Everolimus or a placebo to take orally. The study will also use Tetracycline capsules, which are another type of medication, to help with the research. The trial will last for a period of time during which participants will take the medication and undergo various assessments. These assessments will include checking changes in bone health and muscle function, as well as overall quality of life. The goal is to gather information on how Everolimus affects these aspects of health in older adults.
The study will monitor changes in specific markers in the blood that indicate bone formation and resorption, which is the process of breaking down bone tissue. It will also measure bone density and structure using special scanning techniques. Additionally, muscle strength and function will be evaluated through simple physical tests. The trial is designed to provide valuable insights into how Everolimus might be used to support healthier aging in the elderly population.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
3 criteria
- Men and women aged 65-85 years old, from any ethnic background.
- Be in relatively good general health, with only well-managed chronic diseases like hypertension (high blood pressure) or coronary artery disease (heart-related condition), and be clinically stable.
- Participants should not have health conditions that could limit walking, such as a recent injury.
Who cannot join the trial?
4 criteria
- Patients who are not generally healthy or have unstable medical conditions cannot participate.
- Individuals who are not within the specified age range for the study are excluded.
- Participants who are part of a vulnerable population are not eligible.
- Both men and women can participate, but those who do not meet the gender criteria are excluded.
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Investigated drugs
Everolimus is a medication that is being studied to see if it can help older adults maintain stronger bones and muscles as they age. It is similar to another drug called rapamycin. The researchers want to find out if everolimus can prevent bones from getting weaker and help muscles work better. They are also looking at whether it can reduce some of the biological processes that make people age. This study is focused on understanding how everolimus might help improve the overall health and vitality of elderly individuals by targeting these specific areas.
What is already known about the treatment
Everolimus – Everolimus is administered orally in the form of tablets. It is currently being studied for its potential to enhance musculoskeletal health and slow down aging-related changes in the elderly. The main therapeutic indication being explored is its ability to prevent age-related bone loss and improve muscle function. At the molecular level, everolimus works by inhibiting a protein called mTOR, which plays a role in cell growth and aging processes. It is classified as an mTOR inhibitor in pharmacology.
Investigated diseases
Age-related bone loss – Age-related bone loss is a condition where bones gradually lose density and strength as a person ages. This process is primarily due to an imbalance between bone resorption and bone formation, with resorption outpacing formation. As a result, bones become more fragile and susceptible to fractures. The condition often progresses silently over the years, with no symptoms until a fracture occurs. It commonly affects areas such as the spine, hips, and wrists. Regular physical activity and a balanced diet can help maintain bone health.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IITrial ID2023-509838-19-00Estimated enrolment120 patientsSponsorOdense University Hospital
sourced from the EU Clinical Trials Register and site verification
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